510(k) K904869
K904869 is an FDA 510(k) premarket notification submitted by Kramer Const for the device "ELLIPSE PUNCH". The FDA issued a decision of Substantially Equivalent on March 6, 1991. The device falls under product code LRY (Punch, Surgical), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 6, 1991
- Date Received
- October 29, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Punch, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type